Abstract

FORMULATION AND COMPARATIVE DISSOLUTION STUDY OF LEFLUNOMIDE FILM COATED TABLETS WITH A REFERENCE PRODUCT

Prashanta Basnet*

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Abstract

The main objective of the present study is to conduct the comparative dissolution study of a generic brand of same strength and dosage form and treatment of obtained dissolution data by using similarity factor (ƒ2) to determine whether the formulations used were equivalent or significantly different. Leflunomide is a class II drug as per BCS (Biopharmaceutical Classification System) which means it has a low aqueous solubility and high permeability. It is of utmost importance to understand the release profiles of such drugs to relate with the in vivo availability. Hence, the study was developed to compare the in vitro dissolution profiles of Leflunomide film coated tablets (Lef-20) with a Reference product available in Nepalese market (Lefra- 20) by applying bio-relevant medium (pH 1.2, 4.5 and 6.8 buffers). In vitro dissolution profiles were evaluated in bio-relevant medium in dissolution apparatus and the dissolution curves were compared by the similarity factor (f2). The dissolution profiles of the test and the reference products demonstrated similar disposition in all bio-relevant media. Therefore, dissolution profiles in bio-relevant media in dissolution apparatus may be used as a tool to predict and correlate in vivo disposition of formulations of Leflunomide tablets. Furthermore, it can be argued that bio-waiver can be granted for film coated formulations of Leflunomide on the basis of in vitro dissolution profile.

Keywords: Leflunomide, film coated tablets, similarity factor, BCS, dissolution profile.